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| ID | Type | Description | Link |
|---|---|---|---|
| SMMC- 13861008A |
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Influenza vaccine reduces the cardiovascular events in post-myocardial infarction (MI) patients and in those with stable angina (SA).
A connection between infectious processes and atherosclerosis is repeatedly reported [1]. Acute respiratory infection was found to be associated with myocardial infarction (MI) [2,3] and a number of epidemiological studies found that mortality attributable to cardiovascular diseases is increased during influenza epidemics [4]. Naghavi et al [5] in a case-control study of patients with coronary artery disease (CAD) found that vaccination against influenza was negatively associated with the development of new MI during the same influenza season. While some clinical trials found influenza vaccine effective in secondary prevention of cardiovascular adverse events [6,7], a large trial [8] failed to approve such an efficacy. Furthermore, a recent review of published trials on the subject concluded that frailty selection bias and use of non-specific endpoints such as all cause mortality have led cohort studies to greatly exaggerate vaccine benefits and that the remaining evidence base is currently insufficient to indicate the magnitude of the mortality benefit of the vaccination program [9].
This study aims to assess the efficacy of vaccine in secondary prevention of cardiovascular events in MI and stable angina (SA) patients using specific endpoints including reliable quantitative tools.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza vaccine | Experimental | Enrolled patients who are randomly assigned to receive influenza vaccine |
|
| Placebo | Placebo Comparator | Enrolled patients who are randomly assigned to receive placebo of influenza vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| influenza vaccine | Biological | Intramuscular injection of one 0.5-mL dose of influenza vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular death | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute coronary syndrome (MI or unstable angina) | 6 months | |
| Admission for Coronary Artery Disease | 6 months | |
| Angina severity (Seattle Angina Questionnaire [10]) |
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Inclusion Criteria:
Patients with the diagnosis of acute, evolving or recent MI (after recovered the acute phase) as defined by:
Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following:
Pathologic findings of an acute MI [12]
Patients with stable angina pectoris and documented coronary artery stenosis (angiography).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maryam Keshtkar-Jahromi, M.D.; M.P.H. | Infectious Diseases and Tropical Medicine Research Center, Shaheed Beheshti Medical University, Tehran, Iran | Study Chair |
| Hossein Vakili, M.D. | Cardiovascular Research Center, Shaheed Beheshti Medical University, Tehran, Iran | Principal Investigator |
| Ali Eskandari, MD | Shahid Beheshti University of Medical Sciences | Principal Investigator |
| Mohammad Rahnavardi, MD | Shahid Beheshti University of Medical Sciences | Principal Investigator |
| Sharareh Gholamin, MD | Shaheed Beheshti University (MC) | Principal Investigator |
| Seyed Mostafa Razavi, MD | Shaheed Beheshti University (MC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaheed Modarres Medical Center | Tehran | Tehran Province | 19814 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16375635 | Background | Gurfinkel E, Lernoud V. The role of infection and immunity in atherosclerosis. Expert Rev Cardiovasc Ther. 2006 Jan;4(1):131-7. doi: 10.1586/14779072.4.1.131. | |
| 6695777 | Background | Spodick DH, Flessas AP, Johnson MM. Association of acute respiratory symptoms with onset of acute myocardial infarction: prospective investigation of 150 consecutive patients and matched control patients. Am J Cardiol. 1984 Feb 1;53(4):481-2. doi: 10.1016/0002-9149(84)90016-x. |
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| placebo for influenza vaccine | Biological | Intramuscular injection of one 0.5-mL dose of placebo for influenza vaccine |
|
| 6 months |
| Coronary artery stenosis (modified Gensini score [11]) | 6 months |
| Coronary revascularization (artery bypass graft or percutaneous coronary intervention) | 6 months |
| Influenza infection | 6 months |
| 721358 | Background | Bainton D, Jones GR, Hole D. Influenza and ischaemic heart disease--a possible trigger for acute myocardial infarction? Int J Epidemiol. 1978 Sep;7(3):231-9. doi: 10.1093/ije/7.3.231. |
| 15722256 | Background | Gurevich VS. Influenza, autoimmunity and atherogenesis. Autoimmun Rev. 2005 Feb;4(2):101-5. doi: 10.1016/j.autrev.2004.10.006. Epub 2004 Nov 20. |
| 11120692 | Background | Naghavi M, Barlas Z, Siadaty S, Naguib S, Madjid M, Casscells W. Association of influenza vaccination and reduced risk of recurrent myocardial infarction. Circulation. 2000 Dec 19;102(25):3039-45. doi: 10.1161/01.cir.102.25.3039. |
| 11994246 | Background | Gurfinkel EP, de la Fuente RL, Mendiz O, Mautner B. Influenza vaccine pilot study in acute coronary syndromes and planned percutaneous coronary interventions: the FLU Vaccination Acute Coronary Syndromes (FLUVACS) Study. Circulation. 2002 May 7;105(18):2143-7. doi: 10.1161/01.cir.0000016182.85461.f4. |
| 14563288 | Background | Leon de la Fuente R, Gurfinkel EP, Toledo D, Mautner B; Grupo de Estudio FLUVACS. [Flu vaccination in patients with acute coronary syndromes: treatment benefit in prespecified subgroups]. Rev Esp Cardiol. 2003 Oct;56(10):949-54. doi: 10.1016/s0300-8932(03)76991-7. Spanish. |
| 12244032 | Background | Jackson LA, Yu O, Heckbert SR, Psaty BM, Malais D, Barlow WE, Thompson WW; Vaccine Safety Datalink Study Group. Influenza vaccination is not associated with a reduction in the risk of recurrent coronary events. Am J Epidemiol. 2002 Oct 1;156(7):634-40. doi: 10.1093/aje/kwf073. |
| 17897608 | Background | Simonsen L, Taylor RJ, Viboud C, Miller MA, Jackson LA. Mortality benefits of influenza vaccination in elderly people: an ongoing controversy. Lancet Infect Dis. 2007 Oct;7(10):658-66. doi: 10.1016/S1473-3099(07)70236-0. |
| 7829785 | Background | Spertus JA, Winder JA, Dewhurst TA, Deyo RA, Prodzinski J, McDonell M, Fihn SD. Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease. J Am Coll Cardiol. 1995 Feb;25(2):333-41. doi: 10.1016/0735-1097(94)00397-9. |
| Background | Gensini GG. Coronary Angiography. Mount Kisco, NY: Futura Publishing Co; 1975. |
| 10987628 | Background | Alpert JS, Thygesen K, Antman E, Bassand JP. Myocardial infarction redefined--a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. J Am Coll Cardiol. 2000 Sep;36(3):959-69. doi: 10.1016/s0735-1097(00)00804-4. |
| 40432084 | Derived | Dehesh M, Gholamin S, Razavi SM, Eskandari A, Vakili H, Rahnavardi Azari M, Wang Y, Gough EK, Keshtkar-Jahromi M. Influenza Vaccination and Cardiovascular Outcomes in Patients with Coronary Artery Diseases: A Placebo-Controlled Randomized Study, IVCAD. Vaccines (Basel). 2025 Apr 27;13(5):472. doi: 10.3390/vaccines13050472. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| D060050 | Angina, Stable |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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